Internal Audit Checklist Form
Completion Date: Completed By: QM Version:
Executive Summary:
Corrective Actions (CA):
Preventive Actions (PA):
Improvement Actions (IA):
KEY: OK = Meets criteria C = Comment X = Nonconformity
High = 1 Intermediate = 2 Low = 3
Note: ORANGE highlighted fields represent criteria used during the Laboratory Computer Systems Technical Assessment
Action Plan:
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|No. |Requirement |Compliance |Reference |Objective Evidence |
| | |OK/C/X |Action |Priority | | |
|4 |MANAGEMENT REQUIREMENTS FOR ACCREDITATION |
|4.1 |Organization |
|4.1.1 |The laboratory or the organization of which it is part shall be an | | | | | |
| |entity that can be held legally responsible. | | | | | |
|4.1.2 |It is the responsibility of the laboratory to carry out its testing and| | | | | |
| |calibration activities in such a way as to meet the requirements of | | | | | |
| |this International Standard and to satisfy the needs of the customer, | | | | | |
| |the regulatory authorities or organizations providing recognition. | | | | | |
|4.1.3 |The laboratory management system shall cover work carried out in the | | | | | |
| |laboratory's permanent facilities, at sites away from its permanent | | | | | |
| |facilities, or in associated temporary or mobile facilities. | | | | | |
|4.1.4 |If the laboratory is part of an organization performing activities | | | | | |
| |other than testing and/or calibration, the responsibilities of key | | | | | |
| |personnel in the organization that have an involvement or influence on | | | | | |
| |the testing and/or calibration activities of the laboratory shall be | | | | | |
| |defined in order to identify potential conflicts of interest. | | | | | |
|NOTE 1 |Where a laboratory is part of a larger organization, the organizational| | | | | |
| |arrangements should be such that departments having conflicting | | | | | |
| |interests, such as production, commercial marketing or financing do not| | | | | |
| |adversely influence the laboratory's compliance with the requirements | | | | | |
| |of this International Standard. | | | | | |
|NOTE 2 |If the laboratory wishes to be recognized as a third-party laboratory, | | | | | |
| |it should be able to demonstrate that it is impartial and that it and | | | | | |
| |its personnel are free from any undue commercial, financial and other | | | | | |
| |pressures which might influence their technical judgement. The | | | | | |
| |third-party testing or calibration laboratory should not engage in any | | | | | |
| |activities that may endanger the trust in its independence of judgement| | | | | |
| |and integrity in relation to its testing or calibration activities. | | | | | |
|4.1.5 |The laboratory shall: | | | | | |
|a) |have managerial and technical personnel who, irrespective of other | | | | | |
| |responsibilities have the authority and resources needed to carry out | | | | | |
| |their duties including the implementation, maintenance and improvement | | | | | |
| |of the management system and to identify the occurrence of departures | | | | | |
| |from the management system or from the procedures for performing tests | | | | | |
| |and/or calibrations, and to initiate actions to prevent or minimize | | | | | |
| |such departures (see also 5.2); | | | | | |
|b) |have arrangements to ensure that its management and personnel are free | | | | | |
| |from any undue internal and external commercial, financial and other | | | | | |
| |pressures and influences that may adversely affect the quality of their| | | | | |
| |work; | | | | | |
|c) |have policies and procedures to ensure the protection of its customers’| | | | | |
| |confidential information and proprietary rights, including procedures | | | | | |
| |for protecting the electronic storage and transmission of results; | | | | | |
|e) |define the organization and management structure of the laboratory, its| | | | | |
| |place in any parent organization, and the relationships between quality| | | | | |
| |management, technical operations and support services; | | | | | |
|f) |specify the responsibility, authority and interrelationships of all | | | | | |
| |personnel who manage, perform and verify work affecting the quality of | | | | | |
| |the tests and/or calibrations; | | | | | |
|g) |provide adequate supervision of testing and calibration staff, | | | | | |
| |including trainees, by persons familiar with methods and procedures, | | | | | |
| |purpose of each test and/or calibration, and with the assessment of the| | | | | |
| |test or calibration results; | | | | | |
|h) |have technical management which has overall responsibility for the | | | | | |
| |technical operations and the provision of the resources needed to | | | | | |
| |ensure the required quality of laboratory operations; | | | | | |
|i) |appoint a member of staff as quality manager (however named) who, | | | | | |
| |irrespective of other duties and responsibilities, shall have defined | | | | | |
| |responsibility and authority for ensuring that the management system | | | | | |
| |related to quality is implemented and followed at all times; the | | | | | |
| |quality manager shall have direct access to the highest level of | | | | | |
| |management at which decisions are made on laboratory policy or | | | | | |
| |resources; | | | | | |
|j) |appoint deputies for key managerial personnel. (see Note). | | | | | |
|(k) |ensure that its personnel are aware of the relevance and importance of | | | | | |
| |their activities and how they contribute to the achievement of the | | | | | |
| |objectives of the management system. | | | | | |
|NOTE |Individuals may have more than one function and it may be impractical | | | | | |
| |to appoint deputies for every function. | | | | | |
|(4.1.6 |Top management shall ensure that the appropriate communication | | | | | |
| |processes are established within the laboratory and that communication | | | | | |
| |takes place regarding the effectiveness of the management system. | | | | | |
|4.2 |Management system |
|4.2.1 |The laboratory shall establish, implement and maintain a management | | | | | |
| |system appropriate to the scope of its activities. The laboratory | | | | | |
| |shall document its policies, systems, programs, procedures and | | | | | |
| |instructions to the extent necessary to assure the quality of the test | | | | | |
| |and/or calibration results. The system's documentation shall be | | | | | |
| |communicated to, understood by, available to, and implemented by the | | | | | |
| |appropriate personnel. | | | | | |
|4.2.2 |The laboratory’s management system policies related to quality, | | | | | |
| |including a quality policy statement, shall be defined in a quality | | | | | |
| |manual (however named). The overall objectives shall be established, | | | | | |
| |and shall be reviewed during management review. The quality policy | | | | | |
| |statement shall be issued under the authority of top management. It | | | | | |
| |shall include at least the following: | | | | | |
|a) |the laboratory management’s commitment to good professional practice | | | | | |
| |and to the quality of its testing and calibration in servicing its | | | | | |
| |customers; | | | | | |
|b) |the management’s statement of the laboratory’s standard of service; | | | | | |
|c) |the purpose of the management system related to quality; | | | | | |
|d) |a requirement that all personnel concerned with testing and calibration| | | | | |
| |activities within the laboratory familiarize themselves with the | | | | | |
| |quality documentation and implement the policies and procedures in | | | | | |
| |their work; and | | | | | |
|(e) |the laboratory management’s commitment to comply with this | | | | | |
| |International Standard and to continually improve the effectiveness of | | | | | |
| |the management system. | | | | | |
|NOTE |The quality policy statement should be concise and may include the | | | | | |
| |requirement that tests and/or calibrations shall always be carried out | | | | | |
| |in accordance with stated methods and customers’ requirements. When | | | | | |
| |the test and/or calibration laboratory is part of a larger | | | | | |
| |organization, some quality policy elements may be in other documents. | | | | | |
|(4.2.3 |Top management shall provide evidence of commitment to the development | | | | | |
| |and implementation of the management system and to continually improve | | | | | |
| |its effectiveness. | | | | | |
|(4.2.4 |Top management shall communicate to the organization the importance of | | | | | |
| |meeting customer requirements as well as statutory and regulatory | | | | | |
| |requirements. | | | | | |
|4.2.5 | | | | | | |
|a) |The quality manual shall include or make reference to the supporting | | | | | |
| |procedures including technical procedures. | | | | | |
|b) |It shall outline the structure of the documentation used in the | | | | | |
| |management system. | | | | | |
|4.2.6 |The roles and responsibilities of technical management and the quality | | | | | |
| |manager, including their responsibility for ensuring compliance with | | | | | |
| |this International Standard, shall be defined in the quality manual. | | | | | |
|(4.2.7 |Top management shall ensure that the integrity of the management system| | | | | |
| |is maintained when changes to the management system are planned and | | | | | |
| |implemented. | | | | | |
|4.3 |Document Control |
|4.3.1 |General |
| |The laboratory shall establish and maintain procedures to control all | | | | | |
| |documents that form part of its management system (internally generated| | | | | |
| |or from external sources), such as regulations, standards, other | | | | | |
| |normative documents, test and/or calibration methods, as well as | | | | | |
| |drawings, software, specifications, instructions and manuals. | | | | | |
|4.3.2 |Document Approval and Issue |
|4.3.2.1 | | | | | | |
|4.3.2.2 |The procedure(s) adopted shall ensure that: | | | | | |
|c) |invalid or obsolete documents are promptly removed from all points of | | | | | |
| |issue or use, or otherwise assured against unintended use; | | | | | |
|d) |obsolete documents retained for either legal or knowledge preservation | | | | | |
| |purposes are suitably marked. | | | | | |
|4.3.2.3 |Management system documents generated by the laboratory shall be | | | | | |
| |uniquely identified. Such identification shall include. | | | | | |
|a) |the date of issue and/or revision identification, | | | | | |
|b) |page numbering, | | | | | |
|c) |the total number of pages or a mark to signify the end of the document,| | | | | |
|d) |and the issuing authority(ies). | | | | | |
|4.3.3 |Document changes |
|4.3.3.1 |Changes to documents shall be reviewed and approved by the same | | | | | |
| |function that performed the original review unless specifically | | | | | |
| |designated otherwise. The designated personnel shall have access to | | | | | |
| |pertinent background information upon which to base their review and | | | | | |
| |approval. | | | | | |
|4.3.3.2 |Where practicable, the altered or new text shall be identified in the | | | | | |
| |document or the appropriate attachments. | | | | | |
|a) |If the laboratory's documentation control system allows for the | | | | | |
| |amendment of documents by hand pending the re-issue of the documents, | | | | | |
| |the procedures and authorities for such amendments shall be defined. | | | | | |
|b) |Amendments shall be clearly marked, initialed and dated. A revised | | | | | |
| |document shall be formally re-issued as soon as practicable. | | | | | |
|4.3.3.4 |Procedures shall be established to describe how changes in documents maintained in computerized systems are made and controlled. |
|4.4.1 |The laboratory shall establish and maintain procedures for the review | | | | | |
| |of requests, tenders and contracts. The policies and procedures for | | | | | |
| |these reviews leading to a contract for testing and/or calibration | | | | | |
| |shall ensure that: | | | | | |
|a) |the requirements, including the methods to be used, are adequately | | | | | |
| |defined, documented and understood (see 5.4.2); | | | | | |
|b) |the laboratory has the capability and resources to meet the | | | | | |
| |requirements; | | | | | |
|c) |the appropriate test and/or calibration method is selected and is | | | | | |
| |capable of meeting the customers’ requirements; (see 5.4.2). | | | | | |
|d) |Any differences between the request or tender and the contract shall be| | | | | |
| |resolved before any work commences. Each contract shall be acceptable | | | | | |
| |both to the laboratory and the customer. | | | | | |
|NOTE 1 |The request, tender and contract review shall be conducted in a | | | | | |
| |practical and efficient manner, and the effect of financial, legal and | | | | | |
| |time schedule aspects should be taken into account. For internal | | | | | |
| |customers, reviews of requests, tenders and contracts can be performed | | | | | |
| |in a simplified way. | | | | | |
|NOTE 2 |The review of capability should establish that the laboratory possesses| | | | | |
| |the necessary physical, personnel and information resources, and that | | | | | |
| |the laboratory's personnel have the skills and expertise necessary for | | | | | |
| |the performance of the tests and/or calibrations in question. The | | | | | |
| |review may also encompass results of earlier participation in | | | | | |
| |interlaboratory comparisons or proficiency testing and/or the running | | | | | |
| |of trial test or calibration programs using certified reference | | | | | |
| |materials in order to determine uncertainties of measurement, limits of| | | | | |
| |detection, confidence limits, etc. | | | | | |
|NOTE 3 |A contract may be any written or oral agreement to provide a customer | | | | | |
| |with testing and/or calibration services. | | | | | |
|4.4.2 |Records of reviews, including any significant changes, shall be | | | | | |
| |maintained. Records shall also be maintained of pertinent discussions | | | | | |
| |with a customer relating to the customer’s requirements or the results | | | | | |
| |of the work during the period of execution of the contract. | | | | | |
|NOTE |For review of routine and other simple tasks, the date and the | | | | | |
| |identification (e.g., the initials) of the person in the laboratory | | | | | |
| |responsible for carrying out the contracted work are considered | | | | | |
| |adequate. For repetitive routine tasks, the review need be made only | | | | | |
| |at the initial enquiry stage or on granting of the contract for | | | | | |
| |on-going routine work performed under a general agreement with the | | | | | |
| |customer, provided that the customer’s requirements remain unchanged. | | | | | |
| |For new, complex or advanced testing and/or calibration tasks, a more | | | | | |
| |comprehensive record should be maintained. | | | | | |
|4.4.3 |The review shall also cover any work that is subcontracted by the | | | | | |
| |laboratory. | | | | | |
|4.4.4 |The customer shall be informed of any deviation from the contract. | | | | | |
|4.4.5 |If a contract needs to be amended after work has commenced, the same | | | | | |
| |contract review process shall be repeated and any amendments shall be | | | | | |
| |communicated to all affected personnel. | | | | | |
|4.5 |Subcontracting of tests and calibrations |
|4.5.1 |When a laboratory subcontracts work whether because of unforeseen | | | | | |
| |reasons (e.g., workload, need for further expertise or temporary | | | | | |
| |incapacity) or on a continuing basis (e.g., through permanent | | | | | |
| |subcontracting, agency or franchising arrangements), this work shall be| | | | | |
| |placed with a competent subcontractor. A competent subcontractor is | | | | | |
| |one that, for example, complies with this International Standard for | | | | | |
| |the work in question. | | | | | |
|4.5.2 |The laboratory shall advise the customer of the arrangement in writing | | | | | |
| |and, when appropriate, gain the approval of the customer, preferably in| | | | | |
| |writing. | | | | | |
|4.5.3 |The laboratory is responsible to the client for the subcontractor's | | | | | |
| |work, except in the case where the customer or a regulatory authority | | | | | |
| |specifies which subcontractor is to be used. | | | | | |
|4.5.4 |The laboratory shall maintain a register of all subcontractors that it | | | | | |
| |uses for tests and/or calibrations and a record of the evidence of | | | | | |
| |compliance with this International Standard for the work in question. | | | | | |
|4.6 |Purchasing services and supplies |
|4.6.1 |The laboratory shall have a policy and procedure(s) for the selection | | | | | |
| |and purchasing of services and supplies it uses that affect the quality| | | | | |
| |of the tests and/or calibrations. Procedures shall exist for the | | | | | |
| |purchase, reception and storage of reagents and laboratory consumable | | | | | |
| |materials relevant for the tests and calibrations. | | | | | |
|4.6.2 |The laboratory shall ensure that purchased supplies and reagents and | | | | | |
| |consumable materials that affect the quality of tests and/or | | | | | |
| |calibrations are not used until they have been inspected or otherwise | | | | | |
| |verified as complying with standard specifications or requirements | | | | | |
| |defined in the methods for the tests and/or calibrations concerned. | | | | | |
| |These services and supplies used shall comply with specified | | | | | |
| |requirements. Records of actions taken to check compliance shall be | | | | | |
| |maintained. | | | | | |
|4.6.3 |Purchasing documents for items affecting the quality of laboratory | | | | | |
| |output shall contain data describing the services and supplies ordered.| | | | | |
| |These purchasing documents shall be reviewed and approved for technical| | | | | |
| |content prior to release. | | | | | |
|NOTE |The description may include type, class, grade, precise identification,| | | | | |
| |specifications, drawings, inspection instructions, other technical data| | | | | |
| |including approval of test results, the quality required and the | | | | | |
| |management system standard under which they were made. | | | | | |
|4.6.4 |The laboratory shall evaluate suppliers of critical consumables, | | | | | |
| |supplies and services which affect the quality of testing and | | | | | |
| |calibration, and shall maintain records of these evaluations and list | | | | | |
| |those approved. | | | | | |
|4.7 |Service to the customer |
|4.7.1 |The laboratory shall be willing to cooperate with customers or their | | | | | |
| |representatives cooperation to clarify the customer’s request and to | | | | | |
| |monitor the laboratory's performance in relation to the work performed,| | | | | |
| |provided that the laboratory ensures confidentiality to their | | | | | |
| |customers. | | | | | |
|NOTE 1 |Such cooperation may include: | | | | | |
|a) |providing the customers of the customer’s representative reasonable | | | | | |
| |access to relevant areas of the laboratory for the witnessing of tests | | | | | |
| |and/or calibrations performed for the customer; | | | | | |
|b) |preparation, packaging, and dispatch of test and/or calibration items | | | | | |
| |needed by the customers for verification purposes. | | | | | |
|NOTE 2 |Customer’s value the maintenance of good communication, advice and | | | | | |
| |guidance in technical matters, and opinions and interpretations based | | | | | |
| |on results. Communication with the customer, especially in large | | | | | |
| |assignments, should be maintained throughout the work. The laboratory | | | | | |
| |should inform the customer of any delays or major deviations in the | | | | | |
| |performance of the tests and/or calibrations. | | | | | |
|(4.7.2 |The laboratory shall seek feedback, both positive and negative, from | | | | | |
| |its customers. The feedback shall be used and analyzed to improve the | | | | | |
| |management system, testing and calibration activities and customer | | | | | |
| |service. | | | | | |
|NOTE |Examples of the types of feedback include customer satisfaction surveys| | | | | |
| |and review of test or calibration reports with customers. | | | | | |
|4.8 |Complaints |
| |The laboratory shall have a policy and procedure for the resolution of | | | | | |
| |complaints received from customers or other parties. Records shall be | | | | | |
| |maintained of all complaints and of the investigations and corrective | | | | | |
| |actions taken by the laboratory (see also 4.11). | | | | | |
|4.9 |Control of nonconforming testing and/or calibration work |
|4.9.1 |The laboratory shall have a policy and procedures that shall be | | | | | |
| |implemented when any aspect of its testing and/or calibration work, or | | | | | |
| |the results of this work, do not conform to its own procedures or the | | | | | |
| |agreed requirements of the customer. The policy and procedures shall | | | | | |
| |ensure that: | | | | | |
|a) |the responsibilities and authorities for the management of | | | | | |
| |nonconforming work are designated and actions (including halting of | | | | | |
| |work and withholding of test reports and calibration certificates, as | | | | | |
| |necessary) are defined and taken when nonconforming work is identified;| | | | | |
|b) |an evaluation of the significance of the nonconforming work is made; | | | | | |
|c) |correction is taken immediately, together with any decision about the | | | | | |
| |acceptability of the nonconforming work; | | | | | |
|d) |where necessary, the customer is notified and work is recalled; | | | | | |
|e) |the responsibility for authorizing the resumption of work is defined. | | | | | |
|NOTE |Identification of nonconforming work or problems with the management | | | | | |
| |system or with testing and/or calibration activities can occur at | | | | | |
| |various places within the management system and technical operations. | | | | | |
| |Examples are customer complaints, quality control, instrument | | | | | |
| |calibration, checking of consumable materials, staff observations or | | | | | |
| |supervision, test report and calibration certificate checking, | | | | | |
| |management reviews and internal or external audits. | | | | | |
|4.9.2 |Where the evaluation indicates that the nonconforming work could recur | | | | | |
| |or that there is doubt about the compliance of the laboratory's | | | | | |
| |operations with its own policies and procedures, the corrective action | | | | | |
| |procedures given in 4.11 shall be promptly followed. | | | | | |
|(4.10 |Improvement |
| |The laboratory shall continually improve the effectiveness of its | | | | | |
| |management system through the use of the quality policy, quality | | | | | |
| |objectives, audit results, analysis of data, corrective and preventive | | | | | |
| |actions and management review. | | | | | |
|4.11 |Corrective action |
|4.11.1 |General |
| |The laboratory shall establish a policy and procedure and shall | | | | | |
| |designate appropriate authorities for implementing corrective action | | | | | |
| |when nonconforming work or departures from the policies and procedures | | | | | |
| |in the management system or technical operations have been identified. | | | | | |
|NOTE |A problem with the management system or with the technical operations | | | | | |
| |of the laboratory may be identified through a variety of activities, | | | | | |
| |such as control of nonconforming work, internal or external audits, | | | | | |
| |management reviews, feedback from customers and from staff | | | | | |
| |observations. | | | | | |
|4.11.2 |Cause analysis |
| |The procedure for corrective action shall start with an investigation | | | | | |
| |to determine the root cause(s) of the problem. | | | | | |
|NOTE |Cause analysis is the key and sometimes the most difficult part in the | | | | | |
| |corrective action procedure. Often the root cause is not obvious and | | | | | |
| |thus a careful analysis of all potential causes of the problem is | | | | | |
| |required. Potential causes could include customer requirements, the | | | | | |
| |samples, sample specifications, methods and procedures, staff skills | | | | | |
| |and training, consumables, or equipment and its calibration. | | | | | |
|4.11.3 |Selection and implementation of corrective actions |
|a) |Where corrective action is needed, the laboratory shall identify | | | | | |
| |potential corrective actions. It shall select and implement the | | | | | |
| |action(s) most likely to eliminate the problem and to prevent | | | | | |
| |recurrence. | | | | | |
|b) |Corrective actions shall be to a degree appropriate to the magnitude | | | | | |
| |and the risk of the problem. | | | | | |
|c) |The laboratory shall document and implement any required changes | | | | | |
| |resulting from corrective action investigations. | | | | | |
|4.11.4 |Monitoring of corrective actions |
| |The laboratory shall monitor the results to ensure that the corrective | | | | | |
| |actions taken have been effective. | | | | | |
|4.11.5 |Additional audits |
| |Where the identification of nonconformance’s or departures casts doubts| | | | | |
| |on the laboratory's compliance with its own policies and the | | | | | |
| |procedures, or on its compliance with this International Standard, the | | | | | |
| |laboratory shall ensure that the appropriate areas of activity are | | | | | |
| |audited in accordance with 4.14 as soon as possible. | | | | | |
|NOTE |Such additional audits often follow the implementation of the | | | | | |
| |corrective actions to confirm their effectiveness. An additional audit| | | | | |
| |should be necessary only when a serious issue or risk to the business | | | | | |
| |is identified. | | | | | |
|4.12 |Preventive action |
|4.12.1 | | | | | | |
|a) |Needed improvements and potential sources of nonconformities, either | | | | | |
| |technical or concerning the management system shall be identified. | | | | | |
|(b) |When improvement opportunities are identified or if preventive action | | | | | |
| |is required, action plans shall be developed implemented and monitored | | | | | |
| |to reduce the likelihood of the occurrence of such nonconformities and | | | | | |
| |to take advantage of the opportunities for improvement. | | | | | |
|4.12.2 |Procedures for preventive actions shall include the initiation of such | | | | | |
| |actions and application of controls to ensure that they are effective. | | | | | |
|NOTE 1 |Preventive action is a pro-active process to identify opportunities for| | | | | |
| |improvement rather than a reaction to the identification of problems or| | | | | |
| |complaints. | | | | | |
|NOTE 2 |Apart from the review of the operational procedures, the preventive | | | | | |
| |action might involve analysis of data, including trend and risk | | | | | |
| |analyses and proficiency testing results. | | | | | |
|4.13 |Control of records |
|4.13.1 |General |
|4.13.1.1 |The Laboratory shall establish and maintain procedures for | | | | | |
| |identification, collection, indexing, access, filing, storage, | | | | | |
| |maintenance and disposal of quality and technical records. Quality | | | | | |
| |records shall include reports from internal audits and management | | | | | |
| |reviews as well as records of corrective and preventive actions. | | | | | |
|4.13.1.2 | | | | | | |
|NOTE |Records may be in any media, such as hard copy or electronic media. | | | | | |
|4.13.1.3 |All records shall be held secure and in confidence. | | | | | |
|4.13.1.4 |The laboratory shall have procedures to protect and back-up records stored electronically and to prevent unauthorized access to or amendment of these records. |
|4.13.2.1 | | | | | | |
|NOTE 1 |In certain fields it may be impossible or impracticable to retain | | | | | |
| |records of all original observations. | | | | | |
|NOTE 2 |Technical records are accumulations of data (see 5.4.7) and | | | | | |
| |information, which result from carrying out tests and/or calibrations | | | | | |
| |and which indicate whether specified quality or process parameters are | | | | | |
| |achieved. They may include forms, contracts, work sheets, work books, | | | | | |
| |check sheets, work notes, control graphs, external and internal test | | | | | |
| |reports and calibration certificates, customers’ notes, papers and | | | | | |
| |feedback. | | | | | |
|4.13.2.2 |Observations, data and calculations shall be recorded at the time they are made and shall be identifiable to the specific task. |
|4.14.1 | | | | | | |
|a) |The laboratory shall periodically, and in accordance with a | | | | | |
| |predetermined schedule and procedure, conduct internal audits of its | | | | | |
| |activities to verify that its operations continue to comply with the | | | | | |
| |requirements of the management system and this International Standard. | | | | | |
| |The internal audit program shall address all elements of the management| | | | | |
| |system, including the testing and/or calibration activities. It is the| | | | | |
| |responsibility of the quality manager to plan and organize audits as | | | | | |
| |required by the schedule and requested by management. | | | | | |
|b) |Such audits shall be carried out by trained and qualified personnel who| | | | | |
| |are, wherever resources permit, independent of the activity to be | | | | | |
| |audited. | | | | | |
|NOTE |The cycle for internal auditing shall normally be completed in one | | | | | |
| |year. | | | | | |
|4.14.2 |When audit findings cast doubt on the effectiveness of the operations | | | | | |
| |or on the correctness or validity of the laboratory's test or | | | | | |
| |calibration results, the laboratory shall take timely corrective | | | | | |
| |action, and shall notify customers in writing if investigations show | | | | | |
| |that the laboratory results may have been affected. | | | | | |
|4.14.3 |The area of activity audited, the audit findings and corrective actions| | | | | |
| |that arise from them shall be recorded. | | | | | |
|4.14.4 |Follow-up audit activities shall verify and record the implementation | | | | | |
| |and effectiveness of the corrective action taken. | | | | | |
|4.15 |Management reviews |
|4.15.1 |In accordance with a predetermined schedule and procedure, the | | | | | |
| |laboratory's top management shall periodically conduct a review of the | | | | | |
| |laboratory's management system and testing and/or calibration | | | | | |
| |activities to ensure their continuing suitability and effectiveness, | | | | | |
| |and to introduce necessary changes or improvements. The review shall | | | | | |
| |take account of: | | | | | |
|a) |the suitability of policies and procedures; | | | | | |
|b) |reports from managerial and supervisory personnel; | | | | | |
|c) |the outcome of recent internal audits; | | | | | |
|d) |corrective and preventive actions; | | | | | |
|e) |assessments by external bodies; | | | | | |
|f) |the results of interlaboratory comparisons or proficiency tests; | | | | | |
|g) |changes in the volume and type of the work; | | | | | |
|h) |customer feedback; | | | | | |
|i) |complaints; | | | | | |
|(j) |recommendations for improvement; | | | | | |
|k) |other relevant factors, such as quality control activities, resources | | | | | |
| |and staff training. | | | | | |
|NOTE 1 |A typical period for conducting a management review is once every 12 | | | | | |
| |months. | | | | | |
|NOTE 2 |Results should feed into the laboratory planning system and should | | | | | |
| |include the goals, objectives and action plans for the coming year. | | | | | |
|NOTE 3 |A management review includes consideration of related subjects at | | | | | |
| |regular management meetings. | | | | | |
|4.15.2 | | | | | | |
|a) |Findings from management reviews and the actions that arise from them | | | | | |
| |shall be recorded. | | | | | |
|b) |The management shall ensure that those actions are carried out within | | | | | |
| |an appropriate and agreed timescale. | | | | | |
|5 |TECHNICAL REQUIREMENTS FOR ACCREDITATION |
|5.1 |General |
|5.1.1 |Many factors determine the correctness and reliability of the tests | | | | | |
| |and/or calibrations performed by a laboratory. These factors include | | | | | |
| |contributions from: | | | | | |
|i) |human factors (5.2) | | | | | |
|ii) |accommodation and environmental conditions (5.3) | | | | | |
|iii) |test and calibration methods and method validation (5.4) | | | | | |
|iv) |equipment (5.5) | | | | | |
|v) |measurement traceability (5.6 and Annex B) | | | | | |
|vi) |sampling (5.7) | | | | | |
|vii) |the handling of test and calibration items (5.8). | | | | | |
|5.1.2 |The extent to which the factors contribute to the total uncertainty of | | | | | |
| |measurement differs considerably between (types of) tests and between | | | | | |
| |(types of) calibrations. The laboratory shall take account of these | | | | | |
| |factors in developing test and calibration methods and procedures, in | | | | | |
| |the training and qualification of personnel, and in the selection and | | | | | |
| |calibration of the equipment it uses. | | | | | |
|5.2 |Personnel |
|5.2.1 | | | | | | |
|a) |The laboratory management shall ensure the competence of all who | | | | | |
| |operate specific equipment, perform tests and/or calibrations, evaluate| | | | | |
| |results, and sign test reports and calibration certificates. | | | | | |
|b) |When using staff who are undergoing training, appropriate supervision | | | | | |
| |shall be provided. Personnel performing specific tasks shall be | | | | | |
| |qualified on the basis of appropriate education, training, experience | | | | | |
| |and/or demonstrated skills, as required. | | | | | |
|NOTE 1 |In some technical areas (e.g., non-destructive testing) it may be | | | | | |
| |required that the personnel performing certain tasks hold personnel | | | | | |
| |certification. The laboratory is responsible for fulfilling specified | | | | | |
| |personnel certification requirements. The requirements for personnel | | | | | |
| |certification might by regulatory, included in the standards for | | | | | |
| |specific technical field, or required by the customer. | | | | | |
|NOTE 2 |The personnel responsible for the opinions and interpretation included | | | | | |
| |in test reports should, in addition to the appropriate qualifications, | | | | | |
| |training, experience and satisfactory knowledge of the testing carried | | | | | |
| |out, also have: | | | | | |
|i) |relevant knowledge of the technology used for the manufacturing of the | | | | | |
| |items, materials, products, etc. tested, or the way they are used or | | | | | |
| |intended to be used, and of the defects or degradations which may occur| | | | | |
| |during or in service; | | | | | |
|ii) |knowledge of the general requirements expressed in the legislation and | | | | | |
| |standards; and | | | | | |
|iii) |an understanding of the significance of deviations found with regard to| | | | | |
| |the normal use of the items, materials, products, etc. concerned. | | | | | |
|5.2.2 | | | | | | |
|a) |The management of the laboratory shall formulate the goals with respect| | | | | |
| |to the education, training and skills of the laboratory personnel. | | | | | |
|b) |The laboratory shall have a policy and procedures for identifying | | | | | |
| |training needs and providing training of personnel. | | | | | |
|c) |The training program shall be relevant to the present and anticipated | | | | | |
| |tasks of the laboratory. | | | | | |
|(d) |The effectiveness of the training actions taken shall be evaluated. | | | | | |
|5.2.3 | | | | | | |
|a) |The laboratory shall use personnel who are employed by, or under | | | | | |
| |contract to, the laboratory. | | | | | |
|b) |Where contracted and additional technical and key support personnel are| | | | | |
| |used, the laboratory shall ensure that such personnel are supervised | | | | | |
| |and competent and that they work in accordance with the laboratory's | | | | | |
| |management system. | | | | | |
|5.2.4 |The laboratory shall maintain current job descriptions for managerial, | | | | | |
| |technical and key support personnel involved in tests and/or | | | | | |
| |calibrations. | | | | | |
|NOTE |Job descriptions can be defined in may ways. As a minimum, the | | | | | |
| |following should be defined: | | | | | |
|i) |the responsibilities with respect to performing tests and/or | | | | | |
| |calibrations; | | | | | |
|ii) |the responsibilities with respect to the planning of tests and/or | | | | | |
| |calibrations and evaluation of results; | | | | | |
|iii) |the responsibilities for reporting opinions and interpretations; | | | | | |
|iv) |the responsibilities with respect to method modification and | | | | | |
| |development and validation of new methods; | | | | | |
|v) |expertise and experience required; | | | | | |
|vi) |qualifications and training programs; | | | | | |
|vii) |managerial duties. | | | | | |
|5.2.5 |The management shall authorize specific personnel to perform particular| | | | | |
| |types of sampling, test and/or calibration, to issue test reports and | | | | | |
| |calibration certificates, to give opinions and interpretations and to | | | | | |
| |operate particular types of equipment. The laboratory shall maintain | | | | | |
| |records of the relevant authorization(s), competence, educational and | | | | | |
| |professional qualifications training, skills and experience of all | | | | | |
| |technical personnel, including contracted personnel. This information | | | | | |
| |shall be readily available and shall include the date on which | | | | | |
| |authorization and/or competence is confirmed. | | | | | |
|5.3 |Accommodation and environmental conditions |
|5.3.1 | | | | | | |
|a) |Laboratory facilities for testing and/or calibration, including but not| | | | | |
| |limited to energy sources, lighting and environmental conditions, shall| | | | | |
| |be such as to facilitate correct performance of the tests and/or | | | | | |
| |calibrations. | | | | | |
| |The laboratory shall ensure that the environmental conditions do not | | | | | |
| |invalidate the results or adversely affect the required quality of any | | | | | |
| |measurement. Particular care shall be taken when sampling and test | | | | | |
| |and/or calibrations are undertaken at sites other than a permanent | | | | | |
| |laboratory facility. | | | | | |
|b) |The technical requirements for accommodation and environmental | | | | | |
| |conditions that can affect the results of tests and calibrations shall | | | | | |
| |be documented. | | | | | |
|5.3.2 | | | | | | |
|a) |The laboratory shall monitor, control and record environmental | | | | | |
| |conditions as required by the relevant specifications, methods and | | | | | |
| |procedures or where thy influence the quality of the results. Due | | | | | |
| |attention shall be paid, for example, to biological sterility, dust, | | | | | |
| |electromagnetic disturbances, radiation, humidity, electrical supply, | | | | | |
| |temperature, and sound and vibration levels, as appropriate to the | | | | | |
| |technical activities concerned. | | | | | |
|b) |Tests and calibrations shall be stopped when the environmental | | | | | |
| |conditions jeopardize the results of the tests and/or calibrations. | | | | | |
|5.3.3 |There shall be effective separation between neighboring areas in which | | | | | |
| |there are incompatible activities. Measures shall be taken to prevent | | | | | |
| |cross-contamination. | | | | | |
|5.3.4 |Access to and use of areas affecting the quality of the tests and/or | | | | | |
| |calibrations shall be controlled. The laboratory shall determine the | | | | | |
| |extent of control based on its particular circumstances. | | | | | |
|5.3.5 |Measures shall be taken to ensure good housekeeping in the laboratory. | | | | | |
| |Special procedures shall be prepared where necessary. | | | | | |
|5.4 |Test and calibration methods and method validation |
|5.4.1 |General |
|a) |The laboratory shall use appropriate methods and procedures for all | | | | | |
| |tests and/or calibrations within its scope. These include sampling, | | | | | |
| |handling, transport, storage and preparation of items to be tested | | | | | |
| |and/or calibrated, and, where appropriate, an estimation of the | | | | | |
| |measurement uncertainty as well as statistical techniques for analysis | | | | | |
| |of test and/or calibration data. | | | | | |
|b) |The laboratory shall have instructions on the use and operation of all | | | | | |
| |relevant equipment, and on the handling and preparation of items for | | | | | |
| |testing and/or calibration, or both, where the absence of such | | | | | |
| |instructions could jeopardize the results of tests and/or calibrations.| | | | | |
|d) |Deviation from test and calibration methods shall occur only if the | | | | | |
| |deviation has been documented, technically justified, authorized, and | | | | | |
| |accepted by the customer. | | | | | |
|NOTE |International, regional or national standards or other recognized | | | | | |
| |specifications that contain sufficient and concise information on how | | | | | |
| |to perform the tests and/or calibrations do not need to be supplemented| | | | | |
| |or rewritten as internal procedures if these standards are written in a| | | | | |
| |way that they can be used as published by the operating staff in a | | | | | |
| |laboratory. It may be necessary to provide additional documentation for| | | | | |
| |optional steps in the method or additional details. | | | | | |
|5.4.2 |Selection of methods |
|a) |The laboratory shall use test and/or calibration methods, including | | | | | |
| |methods for sampling, which meet the needs of the customer and which | | | | | |
| |are appropriate for the tests and/or calibrations it undertakes. | | | | | |
| |Methods published in international, regional, or national standards | | | | | |
| |shall preferably be used. The laboratory shall ensure that it uses the| | | | | |
| |latest valid edition of a standard unless it is not appropriate or | | | | | |
| |possible to do so. | | | | | |
|b) |When necessary, the standard shall be supplemented with additional | | | | | |
| |details to ensure consistent application. | | | | | |
|c) |When the customer does not specify the method to be used, the | | | | | |
| |laboratory shall select appropriate methods that have been published | | | | | |
| |either in international, regional or national standards, or by | | | | | |
| |reputable technical organizations, or in relevant scientific texts or | | | | | |
| |journals, or as specified by the manufacturer of the equipment. | | | | | |
| |Laboratory-developed methods or methods adopted by the laboratory may | | | | | |
| |also be used if they are appropriate for the intended use and if they | | | | | |
| |are validated. | | | | | |
|d) |The customer shall be informed as to the method chosen. | | | | | |
|e) |The laboratory shall confirm that it can properly operate standard | | | | | |
| |methods before introducing the tests or calibrations. If the standard | | | | | |
| |method changes, the confirmation shall be repeated. | | | | | |
|f) |The laboratory shall inform the customer when the method proposed by | | | | | |
| |the customer is considered to be inappropriate or out of date. | | | | | |
|5.4.3 |Laboratory developed methods |
|a) |The introduction of test and calibration methods developed by the | | | | | |
| |laboratory for its own use shall be a planned activity and shall be | | | | | |
| |assigned to qualified personnel equipped with adequate resources. | | | | | |
|b) |Plans shall be updated as development proceeds and effective | | | | | |
| |communication amongst all personnel involved shall be ensured. | | | | | |
|5.4.4 |Non-standard methods |
|a) |When it is necessary to use methods not covered by standard methods, | | | | | |
| |these shall be subject to agreement with the customer and shall include| | | | | |
| |a clear specification of the customer’s requirements and the purpose of| | | | | |
| |the test and/or calibration. | | | | | |
|b) |The method developed shall have been validated appropriately before | | | | | |
| |use. | | | | | |
|NOTE |For new test and/or calibration methods, procedures should be developed| | | | | |
| |prior to the tests and/or calibrations being performed and should | | | | | |
| |contain at least the following information: | | | | | |
|a) |appropriate identification; | | | | | |
|b) |scope; | | | | | |
|c) |description of the type of item to be tested or calibrated; | | | | | |
|d) |parameters or quantities and ranges to be determined; | | | | | |
|e) |apparatus and equipment, including technical performance requirements; | | | | | |
|f) |reference standards and reference materials required; | | | | | |
|g) |environmental conditions required and any stabilization period needed; | | | | | |
|h) |description of the procedure, including: | | | | | |
|( |affixing of identification marks, handling, transporting, storing and | | | | | |
| |preparation of items, | | | | | |
|( |checks to be made before the work is started, | | | | | |
|( |checks that the equipment is working properly and, where required, | | | | | |
| |calibration and adjustment of the equipment before each use, | | | | | |
|( |the method of recording the observations and results, | | | | | |
|( |any safety measures to be observed; | | | | | |
|i) |criteria and/or requirements for approval/rejection; | | | | | |
|j) |data to be recorded and method of analysis and presentation; | | | | | |
|k) |the uncertainty or the procedure for estimating uncertainty. | | | | | |
|5.4.5 |Validation of methods |
|5.4.5.1 |Validation is the confirmation by examination and the provision of | | | | | |
| |objective evidence that the particular requirements for a specific | | | | | |
| |intended use are fulfilled. | | | | | |
|5.4.5.2 | | | | | | |
|a) |The laboratory shall validate non-standard methods, | | | | | |
| |laboratory-designed/developed methods, standard methods used outside | | | | | |
| |their intended scope, and amplifications and modifications of standard | | | | | |
| |methods to confirm that the methods are fit for the intended use. The | | | | | |
| |validation shall be as extensive as is necessary to meet the needs of | | | | | |
| |the given application or field of application. | | | | | |
|b) |The laboratory shall record the results obtained, the procedure used | | | | | |
| |for the validation, and a statement as to whether the method is fit for| | | | | |
| |the intended use. | | | | | |
|NOTE 1 |Validation may include procedures for sampling, handling and | | | | | |
| |transportation. | | | | | |
|NOTE 2 |The techniques used for the determination of the performance of a | | | | | |
| |method should be one of, or a combination of the following: | | | | | |
|i) |calibration using reference standards or reference materials; | | | | | |
|ii) |comparison of results achieved with other methods; | | | | | |
|iii) |interlaboratory comparisons; | | | | | |
|iv) |systematic assessment of the factors influencing the results; | | | | | |
|v) |assessment of the uncertainty of the results based on scientific | | | | | |
| |understanding of the theoretical principles of the method and practical| | | | | |
| |experience. | | | | | |
|NOTE 3 |When some changes are made in the validated non-standard methods, the | | | | | |
| |influence of such changes should be documented and, if appropriate, a | | | | | |
| |new validation should be carried out. | | | | | |
|5.4.5.3 |The range and accuracy of the values obtainable from validated methods | | | | | |
| |(e.g., the uncertainty of the results, detection limit, selectivity of | | | | | |
| |the method, linearity, limit of repeatability and/or reproducibility, | | | | | |
| |robustness against external influences and/or cross-sensitivity against| | | | | |
| |interference from the matrix of the sample/test object), as assessed | | | | | |
| |for the intended use, shall be relevant to the customers’ needs. | | | | | |
|NOTE 1 |Validation includes specification of the requirements, determination of| | | | | |
| |the characteristics of the methods, a check that the requirements can | | | | | |
| |be fulfilled by using the method, and a statement on the validity. | | | | | |
|NOTE 2 |As method-development proceeds, regular review should be carried out to| | | | | |
| |verify that the needs of the customer are still being fulfilled. Any | | | | | |
| |change in requirements requiring modifications to the development plan | | | | | |
| |should be approved and authorized. | | | | | |
|NOTE 3 |Validation is always a balance between costs, risks and technical | | | | | |
| |possibilities. There are many cases in which the range and uncertainty| | | | | |
| |of the values (e.g. accuracy, detection limit, selectivity, linearity, | | | | | |
| |repeatability, reproducibility, robustness and cross-sensitivity) can | | | | | |
| |only be given in a simplified way due to lack of information. | | | | | |
|5.4.6 |Estimation of uncertainty of measurement |
|5.4.6.1 |A calibration laboratory, or a testing laboratory performing its own | | | | | |
| |calibrations, shall have and shall apply a procedure to estimate the | | | | | |
| |uncertainty of measurement for all calibrations and types of | | | | | |
| |calibrations. | | | | | |
|5.4.6.2 |Testing laboratories shall have and shall apply procedures for | | | | | |
| |estimating uncertainty of measurement. In certain cases the nature of | | | | | |
| |the test method may preclude rigorous, metrologically and statistically| | | | | |
| |valid calculation of uncertainty of measurement. In these cases the | | | | | |
| |laboratory shall at least attempt to identify all the components of | | | | | |
| |uncertainty and make a reasonable estimation, and shall ensure that the| | | | | |
| |form of reporting of the result does not give a wrong impression of the| | | | | |
| |uncertainty. Reasonable estimation shall be based on knowledge of the | | | | | |
| |performance of the method and on the measurement scope and shall make | | | | | |
| |use of, for example, previous experience and validation data. | | | | | |
|NOTE 1 |The degree of rigor needed in an estimation of uncertainty of | | | | | |
| |measurement depends on factors such as: | | | | | |
|( |the requirements of the test method; | | | | | |
|( |the requirements of the customer; | | | | | |
|( |the existence of narrow limits on which decisions on conformance to a | | | | | |
| |specification are based. | | | | | |
|NOTE 2 |In those cases where a well-recognized test method specifies limits to | | | | | |
| |the values of the major sources of uncertainty of measurement and | | | | | |
| |specifies the form of presentation of calculated results, the | | | | | |
| |laboratory is considered to have satisfied this clause by following the| | | | | |
| |test method and reporting instructions (see 5.10). | | | | | |
|5.4.6.3 |When estimating the uncertainty of measurement, all uncertainty | | | | | |
| |components which are of importance in the given situation shall be | | | | | |
| |taken into account using appropriate methods of analysis. | | | | | |
|NOTE 1 |Sources contributing to the uncertainty include, but are not | | | | | |
| |necessarily limited to, the reference standards and reference materials| | | | | |
| |used, methods and equipment used, environmental conditions, properties | | | | | |
| |and condition of the item being tested or calibrated, and the operator.| | | | | |
|NOTE 2 |The predicted long-term behavior of the tested and/or calibrated item | | | | | |
| |is not normally taken into account when estimating the measurement | | | | | |
| |uncertainty. | | | | | |
|NOTE 3 |For further information, see ISO 5725 and the Guide to the Expression | | | | | |
| |of Uncertainty in Measurement. | | | | | |
|5.4.7 |Control of Data |
|5.4.7.1 |Calculations and data transfers shall be subject to appropriate checks in a systematic manner. |
|5.5.1 | | | | | | |
|a) |The laboratory shall be furnished with all items of sampling, | | | | | |
| |measurement and test equipment required for the correct performance of | | | | | |
| |the tests and/or calibrations (including sampling, preparation of test | | | | | |
| |and/or calibration items, processing and analysis of test and/or | | | | | |
| |calibration data). | | | | | |
|b) |In those cases where the laboratory needs to use equipment outside its | | | | | |
| |permanent control, it shall ensure that the requirements of this | | | | | |
| |International Standard are met. | | | | | |
|5.5.2 | | | | | | |
|c) |Before being placed into service, equipment (including that used for | | | | | |
| |sampling) shall be calibrated or checked to establish that it meets the| | | | | |
| |laboratory's specification requirements and complies with the relevant | | | | | |
| |standard specifications. It shall be checked and/or calibrated before | | | | | |
| |use (see 5.6). | | | | | |
|5.5.3 |Equipment shall be operated by authorized personnel. Up-to-date | | | | | |
| |instructions on the use and maintenance of equipment (including any | | | | | |
| |relevant manuals provided by the manufacturer of the equipment) shall | | | | | |
| |be readily available for use by the appropriate laboratory personnel. | | | | | |
|5.5.4 |Each item of equipment and its software used for testing and | | | | | |
| |calibration and significant to the result shall, when practicable, be | | | | | |
| |uniquely identified. | | | | | |
|b) |the manufacturer’s name, type identification, and serial number or | | | | | |
| |other unique identification; | | | | | |
|c) |check that equipment complies with the specification (see 5.5.2); | | | | | |
|d) |the current location, where appropriate; | | | | | |
|e) |the manufacturer's instructions, if available, or reference to their | | | | | |
| |location; | | | | | |
|f) |dates, results and copies of reports and certificates of all | | | | | |
| |calibrations, adjustments, acceptance criteria, and the due date of | | | | | |
| |next calibration; | | | | | |
|g) |the maintenance plan, where appropriate, and maintenance carried out to| | | | | |
| |date; | | | | | |
|h) |any damage, malfunction, modification or repair to the equipment. | | | | | |
|5.5.6 |The laboratory shall have procedures for safe handling, transport, | | | | | |
| |storage, use and planned maintenance of measuring equipment to ensure | | | | | |
| |proper functioning and in order to prevent contamination or | | | | | |
| |deterioration. | | | | | |
|NOTE |Additional procedures may be necessary when measuring equipment is used| | | | | |
| |outside the permanent laboratory for tests, calibrations or sampling. | | | | | |
|5.5.7 | | | | | | |
|a) |Equipment that has been subjected to overloading or mishandling, gives | | | | | |
| |suspect results, or has been shown to be defective or outside specified| | | | | |
| |limits, shall be taken out of service. It shall be isolated to prevent| | | | | |
| |its use or clearly labeled or marked as being out of service until it | | | | | |
| |has been repaired and shown by calibration or test to perform | | | | | |
| |correctly. | | | | | |
|b) |The laboratory shall examine the effect of the defect or departure from| | | | | |
| |specified limits on previous tests and/or calibrations and shall | | | | | |
| |institute the "Control of nonconforming work" procedure (see 4.9). | | | | | |
|5.5.8 |Whenever practicable, all equipment under the control of the laboratory| | | | | |
| |and requiring calibration shall be labeled, coded or otherwise | | | | | |
| |identified to indicate the status of calibration, including the date | | | | | |
| |when last calibrated and the date of expiration criteria when | | | | | |
| |recalibration is due. | | | | | |
|5.5.9 |When, for whatever reason, equipment goes outside the direct control of| | | | | |
| |the laboratory, the laboratory shall ensure that the function and | | | | | |
| |calibration status of the equipment are checked and shown to be | | | | | |
| |satisfactory before the equipment is returned to service. | | | | | |
|5.5.10 |When intermediate checks are needed to maintain confidence in the | | | | | |
| |calibration status of the equipment, these checks shall be carried out | | | | | |
| |according to a defined procedure. | | | | | |
|5.5.11 |Where calibrations give rise to a set of correction factors, the laboratory shall have procedures to ensure that copies (e.g., in computer software) are correctly updated. |
|5.6.1 |General |
|a) |All equipment used for tests and/or calibrations, including equipment | | | | | |
| |for subsidiary measurements (e.g., for environmental conditions) having| | | | | |
| |a significant effect on the accuracy or validity of the result of the | | | | | |
| |test, calibration or sampling shall be calibrated before being put into| | | | | |
| |service. | | | | | |
|b) |The laboratory shall have an established program and procedure for the | | | | | |
| |calibration of its equipment. | | | | | |
|NOTE |Such a program should include a system for selecting, using, | | | | | |
| |calibrating, checking, controlling and maintaining measurement | | | | | |
| |standards, reference materials used as measurement standards, and | | | | | |
| |measuring and test equipment used to perform tests and calibrations. | | | | | |
|5.6.2 |Specific Requirements |
|5.6.2.1 |Calibration |
|5.6.2.1.1 | | | | | | |
|a) |For calibration laboratories, the program for calibration of equipment | | | | | |
| |shall be designated and operated so as to ensure that calibrations and | | | | | |
| |measurements made by the laboratory are traceable to the International | | | | | |
| |System of Units (SI). | | | | | |
| |A calibration laboratory establishes traceability of its own | | | | | |
| |measurement standards and measuring instruments to the SI by means of | | | | | |
| |an unbroken chain of calibrations or comparisons linking them to | | | | | |
| |relevant primary standards of the SI units of measurement. The link to| | | | | |
| |SI units may be achieved by reference to national measurement | | | | | |
| |standards. National measurement standards may be primary standards, | | | | | |
| |which are primary realizations of the SI units or agreed | | | | | |
| |representations of SI units based on fundamental physical constants, or| | | | | |
| |they may be secondary standards which are standards calibrated by | | | | | |
| |another national metrology institute. | | | | | |
|b) |When using external calibration services, traceability of measurement | | | | | |
| |shall be assured by the use of calibration services from laboratories | | | | | |
| |that can demonstrate competence, measurement capability and | | | | | |
| |traceability. | | | | | |
|c) |The calibration certificates issued by these laboratories shall contain| | | | | |
| |the measurement results, including the measurement uncertainty and/or a| | | | | |
| |statement of compliance with an identified metrological specification | | | | | |
| |(see also 5.10.4.2). | | | | | |
|NOTE 1 |Calibration laboratories fulfilling the requirements of this | | | | | |
| |International Standard are considered to be competent. A calibration | | | | | |
| |certificate bearing an accreditation body logo from a calibration | | | | | |
| |laboratory accredited to this International Standard, for the | | | | | |
| |calibration concerned, is sufficient evidence of traceability to the | | | | | |
| |calibration data reported. | | | | | |
|NOTE 2 |Traceability of SI units of measurement may be achieved by reference to| | | | | |
| |an appropriate primary standard (see VIM:1993, 6.4) or by reference to | | | | | |
| |a natural constant, the value of which in terms of the relevant SI unit| | | | | |
| |is known and recommended by the General Conference of Weight and | | | | | |
| |Measures (CGPM) and the International Committee for Weights and | | | | | |
| |Measures (CIPM). | | | | | |
|NOTE 3 |Calibration laboratories that maintain their own primary standard or | | | | | |
| |representation of SI units based on fundamental physical constants can | | | | | |
| |claim traceability to the SI system only after these standards have | | | | | |
| |been compared, directly or indirectly, with other similar standards of | | | | | |
| |a national metrology institute. | | | | | |
|NOTE 4 |The term "identified metrological specification" means that it must be | | | | | |
| |clear from the calibration certificate which specification the | | | | | |
| |measurements have been compared with, by including the specification or| | | | | |
| |by giving an unambiguous reference to the specification. | | | | | |
|NOTE 5 |When the terms "international standard" or "national standard" are used| | | | | |
| |in connection with traceability, it is assumed that these standards | | | | | |
| |fulfill the properties of primary standards for the realization of SI | | | | | |
| |units. | | | | | |
|NOTE 6 |Traceability to national measurement standards does not necessarily | | | | | |
| |require the use of the national metrology institute of the country in | | | | | |
| |which the laboratory is located. | | | | | |
|NOTE 7 |If a calibration laboratory wishes or needs to obtain traceability from| | | | | |
| |a national metrology institute other than in its own country, this | | | | | |
| |laboratory should select a national metrology institute that actively | | | | | |
| |participated in the activities of BIPM either directly or through | | | | | |
| |regional groups. | | | | | |
|NOTE 8 |The unbroken chain of calibrations or comparisons may be achieved in | | | | | |
| |several steps carried out by different laboratories that can | | | | | |
| |demonstrate traceability. | | | | | |
|5.6.2.1.2 |There are certain calibrations that currently cannot be strictly made | | | | | |
| |in SI units. In these cases calibration shall provide confidence in | | | | | |
| |measurements by establishing traceability to appropriate measurement | | | | | |
| |standards such as: | | | | | |
|a) |the use of certified reference materials provided by a competent | | | | | |
| |supplier to give a reliable physical or chemical characterization of a | | | | | |
| |material; | | | | | |
|b) |the use of specified methods and/or consensus standards that are | | | | | |
| |clearly described and agreed by all parties concerned. | | | | | |
|c) |Participation in a suitable program of interlaboratory comparisons is | | | | | |
| |required where possible. | | | | | |
|5.6.2.2 |Testing |
|5.6.2.2.1 |For testing laboratories, the requirements given in 5.6.2.1 apply for | | | | | |
| |measuring and test equipment with measuring functions used, unless it | | | | | |
| |has been established that the associated contribution from the | | | | | |
| |calibration contributes little to the total uncertainty of the test | | | | | |
| |result. When this situation arises, the laboratory shall ensure that | | | | | |
| |the equipment used can provide the uncertainty of measurement needed. | | | | | |
|NOTE |The extent to which the requirements in 5.6.2.1 should be followed | | | | | |
| |depends on the relative contribution of the calibration uncertainty to | | | | | |
| |the total uncertainty. If calibration is the dominant factor, the | | | | | |
| |requirements should be strictly followed. | | | | | |
|5.6.2.2.2 |Where traceability of measurements to SI units is not possible and/or | | | | | |
| |not relevant, the same requirements for traceability to, for example, | | | | | |
| |certified reference materials, agreed methods and/or consensus | | | | | |
| |standards are required as for calibration laboratories (see 5.6.2.1.2) | | | | | |
|5.6.3 |Reference standards and reference materials. |
|5.6.3.1 |Reference standards |
|a) |The laboratory shall have a program and procedure for the calibration | | | | | |
| |of its reference standards. | | | | | |
|b) |Reference standards shall be calibrated by a body that can provide | | | | | |
| |traceability as described in 5.6.2.1. | | | | | |
|c) |Such reference standards of measurement held by the laboratory shall be| | | | | |
| |used for calibration only and for no other purpose, unless it can be | | | | | |
| |shown that their performance as reference standards would not be | | | | | |
| |invalidated. Reference standards shall be calibrated before and after | | | | | |
| |any adjustment. | | | | | |
|5.6.3.2 |Reference materials |
| |Reference materials shall, where possible, be traceable to SI units of | | | | | |
| |measurement, or to certified reference materials. Internal reference | | | | | |
| |materials shall be checked as far as is technically and economically | | | | | |
| |practicable. | | | | | |
|5.6.3.3 |Intermediate checks |
| |Checks needed to maintain confidence in the calibration status of | | | | | |
| |reference, primary, transfer or working standards and reference | | | | | |
| |materials shall be carried out according to defined procedures and | | | | | |
| |schedules. | | | | | |
|5.6.3.4 |Transport and storage |
| |The laboratory shall have procedures for safe handling, transport, | | | | | |
| |storage and use of reference standards and reference materials in order| | | | | |
| |to prevent contamination or deterioration and in order to protect their| | | | | |
| |integrity. | | | | | |
|NOTE |Additional procedures may be necessary when reference standards and | | | | | |
| |reference materials are used outside the permanent laboratory for | | | | | |
| |tests, calibrations or sampling. | | | | | |
|5.7 |Sampling |
|5.7.1 | | | | | | |
|a) |The laboratory shall have a sampling plan and procedures for sampling | | | | | |
| |when it carries out sampling of substances, materials or products for | | | | | |
| |subsequent testing or calibration. | | | | | |
|b) |The sampling plan as well as the sampling procedure shall be available | | | | | |
| |at the location where sampling is undertaken. Sampling plans shall, | | | | | |
| |whenever reasonable, be based on appropriate statistical methods. The | | | | | |
| |sampling process shall address the factors to be controlled to ensure | | | | | |
| |the validity of the test and calibration results. | | | | | |
|NOTE 1 |Sampling is a defined procedure whereby a part of a substance, material| | | | | |
| |or product is taken to provide for testing or calibration of a | | | | | |
| |representative sample of the whole. Sampling may also be required by | | | | | |
| |the appropriate specification for which the substance, material or | | | | | |
| |product is to be tested or calibrated. In certain cases (e.g., | | | | | |
| |forensic analysis), the sample may not be representative but is | | | | | |
| |determined by availability. | | | | | |
|NOTE 2 |Sampling procedures should describe the selection, sampling plan, | | | | | |
| |withdrawal and preparation of a sample or samples from a substance, | | | | | |
| |material or product to yield the required information. | | | | | |
|5.7.2 |Where the customer requires deviations, additions or exclusions from | | | | | |
| |the documented sampling procedure, these shall be recorded in detail | | | | | |
| |with the appropriate sampling data and shall be included in all | | | | | |
| |documents containing test and/or calibration results, and shall be | | | | | |
| |communicated to the appropriate personnel. | | | | | |
|5.7.3 |The laboratory shall have procedures for recording relevant data and | | | | | |
| |operations relating to sampling that forms part of the testing or | | | | | |
| |calibration that is undertaken. These records shall include the | | | | | |
| |sampling procedure used, the identification of the sampler, | | | | | |
| |environmental conditions (if relevant) and diagrams or other equivalent| | | | | |
| |means to identify the sampling location as necessary and, if | | | | | |
| |appropriate, the statistics the sampling procedures are based upon. | | | | | |
|5.8 |Handling of test and calibration items |
|5.8.1 |The laboratory shall have procedures for the transportation, receipt, | | | | | |
| |handling, protection, storage, retention and/or disposal of test and/or| | | | | |
| |calibration items, including all provisions necessary to protect the | | | | | |
| |integrity of the test or calibration item, and to protect the interests| | | | | |
| |of the laboratory and the customer. | | | | | |
|5.8.2 |The laboratory shall have a system for identifying test and/or | | | | | |
| |calibration items. The identification shall be retained throughout the| | | | | |
| |life of the item in the laboratory. The system shall be designed and | | | | | |
| |operated so as to ensure that items cannot be confused physically or | | | | | |
| |when referred to in records or other documents. The system shall, if | | | | | |
| |appropriate, accommodate a sub-division of groups of items and the | | | | | |
| |transfer of items within and from the laboratory. | | | | | |
|5.8.3 |Upon receipt of the test or calibration item, abnormalities or | | | | | |
| |departures from normal or specified conditions, as described in the | | | | | |
| |test or calibration method, shall be recorded. When there is doubt as | | | | | |
| |to the suitability of an item for test or calibration, or when an item | | | | | |
| |does not conform to the description provided, or the test or | | | | | |
| |calibration required is not specified in sufficient detail, the | | | | | |
| |laboratory shall consult the customer for further instructions before | | | | | |
| |proceeding and shall record the discussion. | | | | | |
|5.8.4 |The laboratory shall have procedures and appropriate facilities for | | | | | |
| |avoiding deterioration, loss or damage to the test or calibration item | | | | | |
| |during storage, handling and preparation. Handling instructions | | | | | |
| |provided with the item shall be followed. When items have to be stored| | | | | |
| |or conditioned under specified environmental conditions, these | | | | | |
| |conditions shall be maintained, monitored and recorded. Where a test | | | | | |
| |or calibration item or a portion of an item is to be held secure, the | | | | | |
| |laboratory shall have arrangements for storage and security that | | | | | |
| |protect the condition and integrity of the secured items or a portion | | | | | |
| |of an item is to be held secure, the laboratory shall have arrangements| | | | | |
| |for storage and security that protect the condition and integrity of | | | | | |
| |the secured items or portions concerned. | | | | | |
|NOTE 1 |Where test items are to be returned into service after testing, special| | | | | |
| |care is required to ensure that they are not damaged or injured during | | | | | |
| |the handling, testing or storing/waiting process. | | | | | |
|NOTE 2 |A sampling procedure and information on storage and transport of | | | | | |
| |samples, including information on sampling factors influencing the test| | | | | |
| |or calibration result, should be provided to those responsible for | | | | | |
| |taking and transporting the samples. | | | | | |
|NOTE 3 |Reasons for keeping a test or calibration item secure can be the | | | | | |
| |reasons of record, safety or value, or to enable complementary tests | | | | | |
| |and/or calibrations to be performed later. | | | | | |
|5.9 |Assuring the quality of test and calibration results |
|5.9.1 |The laboratory shall have quality control procedures for monitoring the| | | | | |
| |validity of tests and calibrations undertaken. The resulting data | | | | | |
| |shall be recorded in such a way that trends are detectable and where | | | | | |
| |practicable, statistical techniques shall be applied to the reviewing | | | | | |
| |of the results. This monitoring shall be planned and reviewed and may | | | | | |
| |include, but not be limited to the following: | | | | | |
|a) |regular use of certified reference materials and/or internal quality | | | | | |
| |control using secondary reference materials; | | | | | |
|b) |participation in interlaboratory comparison or proficiency-testing | | | | | |
| |programs; | | | | | |
|c) |replicate tests or calibrations using the same or different methods; | | | | | |
|d) |retesting or recalibration of retained items; | | | | | |
|e) |correlation of results for different characteristics of an item. | | | | | |
|NOTE |The selected methods should be appropriate for the type and volume of | | | | | |
| |work undertaken. | | | | | |
|(5.9.2 |Quality control data shall be analyzed and, where they are found to be | | | | | |
| |outside pre-defined criteria, planned action shall be taken to correct | | | | | |
| |the problem and to prevent incorrect results from being reported. | | | | | |
|5.10 |Reporting the results |
|5.10.1 |General |
|5.10.1.1 |The results of each test, calibration, or series of tests or | | | | | |
| |calibrations carried out by the laboratory shall be reported | | | | | |
| |accurately, clearly, unambiguously and objectively, and in accordance | | | | | |
| |with any specific instructions in the test or calibration methods. | | | | | |
|5.10.1.2 |The results shall be reported, usually in a test report or a | | | | | |
| |calibration certificate (see note 1), and shall include all the | | | | | |
| |information requested by the customer and necessary for the | | | | | |
| |interpretation of the test or calibration results and all information | | | | | |
| |required by the method used. This information is normally that | | | | | |
| |required by 5.10.2, and 5.10.3 or 5.10.4. | | | | | |
|5.10.1.3 |In the case of tests or calibrations performed for internal customers, | | | | | |
| |or in the case of a written agreement with the customer, the results | | | | | |
| |may be reported in a simplified way. Any information listed in 5.10.2 | | | | | |
| |to 5.10.4 which is not reported to the customer shall be readily | | | | | |
| |available in the laboratory which carried out the tests and/or | | | | | |
| |calibrations. | | | | | |
|NOTE 1 |Test reports and calibration certificates are sometimes called test | | | | | |
| |certificates and calibration reports, respectively. | | | | | |
|NOTE 2 |The test reports or calibration certificates may be issued as hard copy or by electronic data transfer provided that the requirements of this International Standard are met. |
| |Each test report or calibration certificate shall include at least the | | | | | |
| |following information, unless the laboratory has valid reasons for not | | | | | |
| |doing so: | | | | | |
|a) |A title (e.g., "Test Report" or “Calibration Certificate"); | | | | | |
|b) |the name and address of the laboratory, and the location where the | | | | | |
| |tests and/or calibrations were carried out, if different from the | | | | | |
| |address of the laboratory; | | | | | |
|c) |unique identification of the test report or calibration certificate | | | | | |
| |(such as the serial number), and on each page the identification in | | | | | |
| |order to ensure that the page is recognized as part of the test report | | | | | |
| |or calibration certificate, and a clear identification of the end of | | | | | |
| |the test report or calibration certificate; | | | | | |
|d) |the name and address of the customer; | | | | | |
|e) |identification of the method used; | | | | | |
|f) |a description of, the condition of, and unambiguous identification of | | | | | |
| |the item(s) tested or calibrated; | | | | | |
|g) |the date of receipt of the test or calibration item(s) where this is | | | | | |
| |critical to the validity and application of the results, and the | | | | | |
| |date(s) of performance of the test or calibration; | | | | | |
|h) |reference to the sampling plan and procedures used by the laboratory or| | | | | |
| |other bodies where these are relevant to the validity or application of| | | | | |
| |the results; | | | | | |
|i) |the test or calibration results with, where appropriate, the units of | | | | | |
| |measurement; | | | | | |
|j) |the name(s), function(s) and signature(s) or equivalent identification | | | | | |
| |of person(s) authorizing the test report or calibration certificate; | | | | | |
|NOTE 1 |Hard copies of test reports and calibration certificates should also | | | | | |
| |include the page number and total number of pages. | | | | | |
|NOTE 2 |It is recommended that laboratories include a statement specifying that| | | | | |
| |the test report or calibration certificate shall not be reproduced | | | | | |
| |except in full, without written approval of the laboratory. | | | | | |
|5.10.3 |Test reports |
|5.10.3.1 |In addition to the requirements listed in 5.10.2, test reports shall, | | | | | |
| |where necessary for the interpretation of the test results, include the| | | | | |
| |following: | | | | | |
|a) |deviations from, additions to, or exclusions from the test method, and | | | | | |
| |information on specific test conditions, such as environmental | | | | | |
| |conditions; | | | | | |
|b) |where relevant, a statement of compliance/non-compliance with | | | | | |
| |requirements and/or specifications; | | | | | |
|c) |where applicable, a statement on the estimated uncertainty of | | | | | |
| |measurement; information on uncertainty is needed in test reports when | | | | | |
| |it is relevant to the validity or application of the test results, when| | | | | |
| |a customer’s instructions so requires, or when the uncertainty affects | | | | | |
| |compliance to a specification limit; | | | | | |
|d) |where appropriate and needed, opinions and interpretations (see | | | | | |
| |5.10.5); | | | | | |
|e) |additional information which may be required by specific methods, | | | | | |
| |customers or groups of customers. | | | | | |
|5.10.3.2 |In addition to the requirements listed in 5.10.2 and 5.10.3.1, test | | | | | |
| |reports containing the results of sampling shall include the following,| | | | | |
| |where necessary for the interpretation of test results: | | | | | |
|a) |the date of sampling; | | | | | |
|b) |unambiguous identification of the substance, material or product | | | | | |
| |sampled (including the name of the manufacturer, the model or type of | | | | | |
| |designation and serial numbers as appropriate); | | | | | |
|c) |the location of sampling, including any diagrams, sketches or | | | | | |
| |photographs; | | | | | |
|d) |a reference to the sampling plan and procedures used; | | | | | |
|e) |details of any environmental conditions during sampling that may affect| | | | | |
| |the interpretation of the test results; | | | | | |
|f) |any standard or other specification for the sampling method or | | | | | |
| |procedure, and deviations, additions to or exclusions from the | | | | | |
| |specification concerned. | | | | | |
|5.10.4 |Calibration certificates |
| |In addition to the requirements listed in 5.10.2, calibration | | | | | |
| |certificates shall include the following, where necessary for the | | | | | |
| |interpretation of calibration results: | | | | | |
|a) |the conditions (e.g., environmental) under which the calibrations were | | | | | |
| |made that have an influence on the measurement results; | | | | | |
|b) |the uncertainty of measurement and/or a statement of compliance with an| | | | | |
| |identified metrological specification or clauses thereof; | | | | | |
|c) |evidence that the measurements are traceable (see note 2 in 5.6.2.1.1).| | | | | |
|5.10.4.2 |The calibration certificate shall relate only to quantities and the | | | | | |
| |results of functional tests. If a statement of compliance with a | | | | | |
| |specification is made, this shall identify which clauses of the | | | | | |
| |specification are met or not met. | | | | | |
| |When a statement of compliance with a specification is made omitting | | | | | |
| |the measurement results and associated uncertainties, the laboratory | | | | | |
| |shall record those results and maintain them for possible future | | | | | |
| |reference. | | | | | |
| |When statements of compliance are made, the uncertainty of measurement | | | | | |
| |shall be taken into account. | | | | | |
|5.10.4.3 |When an instrument for calibration has been adjusted or repaired, the | | | | | |
| |calibration results before and after adjustment or repair, if | | | | | |
| |available, shall be reported. | | | | | |
|5.10.4.4 |A calibration certificate (or calibration label) shall not contain any | | | | | |
| |recommendation on the calibration interval except where this has been | | | | | |
| |agreed with the customer. This requirement may be superseded by legal | | | | | |
| |regulations. | | | | | |
|5.10.5 |Opinions and interpretations |
| |When opinions and interpretations are included, the laboratory shall | | | | | |
| |document the basis upon which the opinions and interpretations have | | | | | |
| |been made. Opinions and interpretations shall be clearly marked as | | | | | |
| |such in a test report. | | | | | |
|NOTE 1 |Opinions and interpretations should not be confused with inspections | | | | | |
| |and product certifications as intended in ISO/IEC 17020 and ISO/IEC | | | | | |
| |Guide 65. | | | | | |
|NOTE 2 |Opinions and interpretations included in a test report may comprise, | | | | | |
| |but not be limited to the following: | | | | | |
|a) |an opinion on the statement of compliance/noncompliance of the results | | | | | |
| |with requirements; | | | | | |
|b) |fulfillment of contractual requirements; | | | | | |
|c) |recommendations on how to use the results; | | | | | |
|d) |guidance to be used for improvements. | | | | | |
|NOTE 3 |In many cases it might be appropriate to communicate the opinions and | | | | | |
| |interpretations by direct dialogue with the customer. Such dialogue | | | | | |
| |should be written down. | | | | | |
|5.10.6 |Testing and calibration results obtained from subcontractors |
| |When the test report contains results of tests performed by | | | | | |
| |subcontractors, these results shall be clearly identified. The | | | | | |
| |subcontractor shall report the results in writing or electronically. | | | | | |
| |When a calibration has been subcontracted, the laboratory performing | | | | | |
| |the work shall issue the calibration certificate to the contracting | | | | | |
| |laboratory. | | | | | |
|5.10.7 |Electronic transmission of results |
| |In the case of transmission of test or calibration results by telephone, telex, facsimile or other electronic or electromagnetic means, the requirements of this International Standard shall be met |
| |(see also 5.4.7). |
| |The format shall be designed to accommodate each type of test or | | | | | |
| |calibration carried out and to minimize the possibility of | | | | | |
| |misunderstanding or misuse. | | | | | |
|NOTE 1 |Attention should be given to the layout of the test report or | | | | | |
| |calibration certificate, especially with regard to the presentation of | | | | | |
| |the test or calibration data and ease of assimilation by the reader. | | | | | |
|NOTE 2 |The headings should be standardized as far as possible. | | | | | |
|5.10.9 |Amendments to test reports and calibration certificates |
| |Material amendments to a test report or calibration certificate after | | | | | |
| |issue shall be made only in the form of a further document, or data | | | | | |
| |transfer, which includes the statement: “Supplement to Test Report (or | | | | | |
| |Calibration Certificate), serial number…(or otherwise identified)”, or | | | | | |
| |an equivalent form of wording. | | | | | |
| |Such amendments shall meet all the requirements of this International | | | | | |
| |Standard. | | | | | |
| |When it is necessary to issue a complete new report or calibration | | | | | |
| |certificate, this shall be uniquely identified and shall contain a | | | | | |
| |reference to the original that it replaces. | | | | | |
Objective Evidence
(Attachments)
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